C.01.048(1) Where a person who is a physician, dentist, veterinary surgeon or pharmacist registered and entitled to practise that person’s profession in a province has signed an order specifying the brand name, proper name or common name and the quantity of a drug, other than

(b) keep those records and all orders received for drugs in accordance with section C.01.048 for a period of not less than two years from the date upon which the distribution referred to in the records was made.

SOR/93-202, s. 10.

Recalls

C.01.051 Where a manufacturer who sells a drug in dosage form or a person who imports into and sells in Canada a drug in dosage form commences a recall of the drug, the manufacturer or importer shall forthwith submit to the Director the following information:

(a) the proper name of the drug, the common name of the drug if there is no proper name, the brand name of the drug and the lot number;

(b) in the case of an imported drug, the names of the manufacturer and importer;

Limits of Variability

C.01.061(1) Where the net amount of a drug in a package is not expressed on the label in terms of number of dosage units, any 10 packages of the drug selected as provided by official method DO-31, Determination of Net Contents, dated December 7, 1988, shall contain an amount of the drug such that, when determined by that official method, the average of the net amounts of the drug in the 10 packages is not less than the net amount of the drug shown on the label.

(2) Where the net amount of a drug in a package is expressed on the label in terms of the number of dosage units, any 10 packages of the drug selected as provided by official method DO-31, Determination of Net Contents, dated December 7, 1988, shall contain a number of units such that, when determined by that official method,

(a) the average number of dosage units in the 10 packages is not less than the number of dosage units shown on the label;

(b) no package contains less than the number of dosage units shown on the label except as provided in the table; and

(c) where the drug is a controlled drug as defined in subsection G.01.001(1) or a narcotic as defined in the Narcotic Control Regulations, no package contains more than the number of dosage units shown on the label except as provided in the table to this section.

TABLE

Item

Column I

Column II

Labelled Number of Dosage Units Per Package

Permitted Variation from the Labelled Number

1

50 or less

0

2

More than 50, but less than 101

1

3

101 or more

the greater of one unit or 0.75% of the labelled number, rounded up to the next whole number

SOR/82-429, s. 4;

SOR/89-455, s. 4;

SOR/97-228, s. 3.

C.01.062(1) Subject to subsections (2) to (5), no manufacturer shall sell a drug in dosage form where the amount of any medicinal ingredient therein, determined using an acceptable method, is

(a) less than 90.0 per cent of the amount of the medicinal ingredient shown on the label; or

(b) more than 110.0 per cent of the amount of the medicinal ingredient shown on the label.

(2) Subject to subsection (5), where a drug in dosage form contains a medicinal ingredient that is a volatile substance of botanical origin or its synthetic equivalent, the amount of that ingredient, determined using an acceptable method, shall be

(a) not less than 85.0 per cent of the amount of the medicinal ingredient shown on the label; and

(b) not more than 120.0 per cent of the amount of the medicinal ingredient shown on the label.

(3) Subject to subsection (5), where a drug in capsule form contains a medicinal ingredient that is a vitamin in a fish-liver oil, no variation from the amount of the medicinal ingredient as shown on the label, determined using an acceptable method, is permitted other than that which is in accordance with the variation for that fish-liver oil as stated in any publication whose name is referred to in Schedule B to the Act.

(4) Subject to subsection (5), where a drug in dosage form contains a medicinal ingredient that is a vitamin, no variation from the amount of the medicinal ingredient shown on the label, determined using an acceptable method, is permitted other than the variation set out in column III or IV of an item of the table to this section opposite the vitamin set out in column I of that item for the amount of vitamin set out in column II of that item.

(c) a drug for which a standard is contained in any publication whose name is referred to in Schedule B to the Act;

(d) a drug described in Schedule C or D to the Act or Division 6 of Part C of these Regulations; or

(e) a drug for which a drug identification number has been assigned under subsection C.01.014.2(1) and in respect of which

(i) the conditions of pharmaceutical production and quality control are suitable for controlling the identity, quality, purity, stability, safety, strength and potency of the drug,

(ii) all labels to be used in connection with the drug, including any package insert and any document that is provided on request and that sets out supplementary information on the use of the drug, make proper claims in respect of the drug,

(iii) the drug can, without undue foreseeable risk to humans, be used for the purposes and under the conditions of use recommended by the manufacturer, and

(iv) the drug is effective for the purposes and under the conditions of use recommended by the manufacturer.

TABLE

Item

Column I

Column II

Column III

Column IV

Vitamin

Recommended daily dose

Limits of variation when the recommended daily dose shown on label is equal to or less then amount set out in column II

Limits of variation when the recommended daily dose shown on label is greater than amount set out in column II